FDA Adverse Event
Injury
Summary report: N
STAR S4 IR EXCIMER LASER
MDR report key: 3173617
·
Received June 17, 2013
Report
- Report Number
- 3006695864-2013-00214
- Event Type
- Injury
- Date Received
- June 17, 2013
- Date of Event
- January 10, 2013
- Report Date
- May 24, 2013
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- LZS
- PMA / PMN Number
- P930016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVENT DATE: (B)(6) 2013. PLACEHOLDER.
Additional Manufacturer Narrative · 1
(B)(4) THE AMO FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AT THE CUSTOMER LOCATION AND NO ISSUES WERE FOUND THAT RELATED TO THE REPORTED ISSUE. FIELD SERVICE PERFORMED ROUTINE CALIBRATIONS TO OPTIMIZE SETTINGS AND ALIGNMENTS. PLACEHOLDER .
Description of Event or Problem · 1
THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED AT THE THREE MONTH POST OP EXAM WITH CENTRAL ISLANDS IN THE RIGHT EYE FOLLOWING LASER SCRAPE PRK (PHOTOREFRACTIVE KERATECTOMY) PROCEDURE. THE CLINIC REPORTED THAT THERE WAS NO LOSS OF VISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273817 | STAR S4 IR EXCIMER LASER | EXCIMER LASER | LZS | ABBOTT MEDICAL OPTICS | STAR S4 IR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other |